Immunization, not vaccination: monoclonal antibodies for infant RSV prevention and the US vaccines for children program

References

• Suh M, Movva N, Jiang X, et al. Respiratory syncytial virus is the leading cause of United States infant hospitalizations, 2009-2019: a study of the national (nationwide) inpatient sample. J Infect Dis. 2022;226(Suppl 2):S154–S163. doi:10.1093/infdis/jiac120.
   PubMed Web of Science ®Google Scholar
• Glezen WP, Taber LH, Frank AL, et al. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child. 1986;140(6):543–546. doi:10.1001/archpedi.1986.02140200053026.
   PubMedGoogle Scholar
• Arriola CS, Kim L, Langley G, et al. Estimated burden of Community-Onset respiratory syncytial Virus-Associated hospitalizations among children aged <2 years in the United States, 2014-15. J Pediatric Infect Dis Soc. 2020;9(5):587–595. doi:10.1093/jpids/piz087.
   PubMed Web of Science ®Google Scholar
• Lively JY, Curns AT, Weinberg GA, et al. Respiratory syncytial Virus-Associated outpatient visits among children younger than 24 months. J Pediatric Infect Dis Soc. 2019;8(3):284–286. doi:10.1093/jpids/piz011.
   PubMed Web of Science ®Google Scholar
• Shi N, Palmer L, Chu B-C, et al. Association of RSV lower respiratory tract infection and subsequent healthcare use and costs: a medicaid claims analysis in early-preterm, late-preterm, and full-term infants. J Med Econ. 2011;14(3):335–340. doi:10.3111/13696998.2011.578188.
   PubMedGoogle Scholar
• Bowser DM, Rowlands KR, Hariharan D, et al. Cost of respiratory syncytial virus infections in US infants: systematic literature review and analysis. J Infect Dis. 2022;226(Suppl 2):S225–S235. doi:10.1093/infdis/jiac172.
   PubMed Web of Science ®Google Scholar
• Leader S, Yang H, DeVincenzo J, et al. Time and out-of-pocket costs associated with respiratory syncytial virus hospitalization of infants. Value Health. 2003;6(2):100–106. doi:10.1046/j.1524-4733.2003.00220.x.
   PubMed Web of Science ®Google Scholar
• Karron RA. Respiratory syncytial virus vaccines. In: Plotkin SA, Orenstein WA, Offit PA, et al., editors. Philadelphia (PA): Elsevier; 2018. p. 943–949.e4.
   Google Scholar
• Nair H, Nokes DJ, Gessner BD, et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010;375(9725):1545–1555. doi:10.1016/S0140-6736(10)60206-1.
   PubMed Web of Science ®Google Scholar
• Shi T, McAllister DA, O'Brien KL, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study. Lancet. 2017;390(10098):946–958. doi:10.1016/S0140-6736(17)30938-8.
   PubMed Web of Science ®Google Scholar
• National Foundation for Infectious Diseases. Call to Action: reducing the Burden of RSV across the Lifespan (January 2022) [Internet]. National Foundation for Infectious Diseases. 2022 https://www.nfid.org/publications/call-to-action-reducing-the-burden-of-rsv-across-the-lifespan/.
   Google Scholar
• Hall CB, Weinberg GA, Blumkin AK, et al. Respiratory syncytial virus–associated hospitalizations among children less than 24 months of age. Pediatrics. 2013;132(2):e341–e348. doi:10.1542/peds.2013-0303.
   PubMed Web of Science ®Google Scholar
• Boyce TG, Mellen BG, Mitchel EF, et al. Rates of hospitalization for respiratory syncytial virus infection among children in medicaid. J Pediatr. 2000;137(6):865–870. doi:10.1067/mpd.2000.110531.
   PubMed Web of Science ®Google Scholar
• Parikh RC, McLaurin KK, Margulis AV, et al. Chronologic age at hospitalization for respiratory syncytial virus among preterm and term infants in the United States. Infect Dis Ther. 2017;6(4):477–486. doi:10.1007/s40121-017-0167-9.
   PubMed Web of Science ®Google Scholar
• Rose EB, Wheatley A, Langley G, et al. Respiratory syncytial virus seasonality—United States. MMWR Morb Mortal Wkly Rep. 2018;67(2):71–76.
   PubMed Web of Science ®Google Scholar
• Olsen SJ, Winn AK, Budd AP, et al. Changes in influenza and other respiratory virus activity during the COVID-19 pandemic—United States. MMWR Morb Mortal Wkly Rep. 2020;70:2021–2021. https://www.cdc.gov/mmwr/volumes/70/wr/mm7029a1.htm
   Web of Science ®Google Scholar
• Zheng Z, Warren JL, Shapiro ED, et al. Estimated incidence of respiratory hospitalizations attributable to RSV infections across age and socioeconomic groups. Pneumonia. 2022;14(1):6. doi:10.1186/s41479-022-00098-x.
   Web of Science ®Google Scholar
• Glaser EL, Hariharan D, Bowser DM, et al. Impact of respiratory syncytial virus on child, caregiver, and family quality of life in the United States: systematic literature review and analysis. J Infect Dis. 2022;226(Suppl 2):S236–S245. doi:10.1093/infdis/jiac183.
   PubMed Web of Science ®Google Scholar
• Simões EAF, Chirikov V, Botteman M, et al. Long-term assessment of healthcare utilization 5 years after respiratory syncytial virus infection in US infants. J Infect Dis. 2020;221:1256–1270.
   PubMed Web of Science ®Google Scholar
• Esposito S, Abu Raya B, Baraldi E, et al. RSV prevention in all infants: which is the most preferable strategy? Front Immunol. 2022;13:880368.
   PubMed Web of Science ®Google Scholar
• Nurmagambetov T, Kuwahara R, Garbe P. The economic burden of asthma in the United States, 2008-2013. Ann Am Thorac Soc. 2018;15(3):348–356. doi:10.1513/AnnalsATS.201703-259OC.
   PubMed Web of Science ®Google Scholar
• Bont L, Weil Olivier C, Herting E, et al. The assessment of future RSV immunizations: how to protect all infants? Front Pediatr. 2022;10:981741.
   PubMed Web of Science ®Google Scholar
• Mac S, Sumner A, Duchesne-Belanger S, et al. Cost-effectiveness of palivizumab for respiratory syncytial virus: a systematic review. Pediatrics. 2019;143:e20184064. doi:10.1542/peds.2018-4064.
   PubMed Web of Science ®Google Scholar
• Cohen J. Two new medicines may curb serious respiratory disease in infants. 2020 https://www.science.org/content/article/two-new-medicines-may-curb-serious-respiratory-disease-infants.
   Google Scholar
• Ananworanich J, Heaton PM. Bringing preventive RSV monoclonal antibodies to infants in low- and Middle-Income countries: challenges and opportunities. Vaccines. 2021;9:961. doi:10.3390/vaccines9090961.
   Web of Science ®Google Scholar
• Institute for Quality and Efficiency in Health Care. The innate and adaptive immune systems. Cologne, Germany: Institute for Quality and Efficiency in Health Care (IQWiG); 2020
   Google Scholar
• Alberts B, Johnson A, Lewis J, et al. The adaptive immune system. In: Molecular biology of the cell. 4th ed. New York: Garland Science; 2002. https://www.ncbi.nlm.nih.gov/books/NBK21070/
   Google Scholar
• Centers for Disease Control and Prevention. Types of Immunity to a Disease [Internet] 2022. https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm
   Google Scholar
• Eichinger KM, Kosanovich JL, Lipp M, et al. Strategies for active and passive pediatric RSV immunization. Ther Adv Vaccines Immunother. 2021;9:2515135520981516. doi:10.1177/2515135520981516.
   Google Scholar
• Li Y, Hodgson D, Wang X, et al. Respiratory syncytial virus seasonality and prevention strategy planning for passive immunisation of infants in low-income and Middle-income countries: a modelling study. Lancet Infect Dis. 2021;21(9):1303–1312. doi:10.1016/S1473-3099(20)30703-9.
   PubMed Web of Science ®Google Scholar
• Jewett CF, Approves RSV. Shot for Infants. The New York Times [Internet] 2023. https://www.nytimes.com/2023/07/17/health/rsv-infants-fda.html
   Google Scholar
• Domachowske J, Madhi SA, Simões EAF, et al. Safety of nirsevimab for RSV in infants with heart or lung disease or prematurity. N Engl J Med. 2022;386(9):892–894. doi:10.1056/NEJMc2112186.
   PubMed Web of Science ®Google Scholar
• Simões EAF, Madhi SA, Muller WJ, et al. Efficacy of nirsevimab against respiratory syncytial virus lower respiratory tract infections in preterm and term infants, and pharmacokinetic extrapolation to infants with congenital heart disease and chronic lung disease: a pooled analysis of randomised controlled trials. Lancet Child Adolesc Health. 2023;7(3):180–189. doi:10.1016/S2352-4642(22)00321-2.
   PubMedGoogle Scholar
• Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP) Charter [Internet]. 2022 https://www.cdc.gov/vaccines/acip/committee/charter.html
   Google Scholar
• National Information Center on Health Services Research & Health Care Technology. HTA 101: Introduction to Health Technology Assessment [Internet]. U.S. National Library of Medicine; 2019. https://www.nlm.nih.gov/nichsr/hta101/ta10103.html
   Google Scholar
• Centers for Disease Control and Prevention. ACIP Evidence to Recommendations Framework. https://www.cdc.gov/vaccines/acip/recs/grade/downloads/acip-evidence-recs-framework.pdf
   Google Scholar
• Centers for Disease Control and Prevention. Who Sets the Immunization Schedule?. Centers for Disease Control and Prevention. 2021. https://www.cdc.gov/vaccines/parents/schedules/sets-schedule.html
   Google Scholar
• Bell BP, Romero JR, Lee GM. Scientific and ethical principles underlying recommendations from the advisory committee on immunization practices for COVID-19 vaccination implementation. JAMA. 2020;324(20):2025–2026. doi:10.1001/jama.2020.20847.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. About the Vaccines for Children Program (VFC). [Internet]. 2023. https://www.cdc.gov/vaccines/programs/vfc/about/index.html
   Google Scholar
• Centers for Disease Control and Prevention. ACIP Resolutions for Vaccines for Children (VFC) Program [Internet]. 2023. https://www.cdc.gov/vaccines/programs/vfc/providers/resolutions.html
   Google Scholar
• Centers for Disease Control and Prevention. Immunization Schedules for 18 & Younger [Internet]. Centers for Disease Control and Prevention. 2023. https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html
   Google Scholar
• Smagh K. Advisory committee on immunization practices. Action: notice and request for comment [internet]. Report No.: Docket No. CDC-2023-0063. Centers for Disease Control and Prevention. 2023. https://public-inspection.federalregister.gov/2023-15190.pdf
   Google Scholar
• Oliver S. Updates to COVID-19 vaccine policy: considerations for Future Planning [Internet]. 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-04-19/06-COVID-Oliver-508.pdf.
   Google Scholar
• Ku L, Tyler F, Simon M. Vaccines for Children Program: early Legislative History and Future Innovations [Internet]. The George Washington University Milken Institute School of Public Health; 2022. Available from: http://gwhpmmatters.com/sites/default/files/2022-10/VFC_Legislative%20History%20final%2010-13-22%5B9%5D.pdf.
   Google Scholar
• Neumann PJ, Ganiats TG, Russell LB, et al. editors. Cost-Effectiveness in health and medicine. 2nd ed. New York: Oxford University Press; 2016. https://oxford.universitypressscholarship.com/10.1093/acprof:oso/9780190492939.001.0001/acprof-9780190492939
   Google Scholar
• Adler MD. Measuring social welfare: an introduction. New York: Oxford University Press; 2019. https://oxford.universitypressscholarship.com/10.1093/oso/9780190643027.001.0001/oso-9780190643027
   Google Scholar
• Gandon S, Mackinnon MJ, Nee S, et al. Imperfect vaccines and the evolution of pathogen virulence. Nature. 2001;414(6865):751–756. doi:10.1038/414751a.
   PubMed Web of Science ®Google Scholar
• Anderson EJ, Carosone-Link P, Yogev R, et al. Effectiveness of palivizumab in high-risk infants and children: a propensity score weighted regression analysis. Pediatr Infect Dis J. 2017;36(8):699–704. doi:10.1097/INF.0000000000001533.
   PubMed Web of Science ®Google Scholar
• Kampmann B, Madhi SA, Munjal I, et al. Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. N Engl J Med. 2023;388(16):1451–1464. doi:10.1056/NEJMoa2216480.
   PubMed Web of Science ®Google Scholar
• Lee C, Gong Y, Brok J, et al. Effect of hepatitis B immunisation in newborn infants of mothers positive for hepatitis B surface antigen: systematic review and meta-analysis. BMJ. 2006;332(7537):328–336. doi:10.1136/bmj.38719.435833.7C.
   PubMed Web of Science ®Google Scholar
• Rus M, Groselj U. Ethics of vaccination in childhood—a framework based on the four principles of biomedical ethics. Vaccines. 2021;9:113. doi:10.3390/vaccines9020113.
   Web of Science ®Google Scholar
• Shaughnessy AF. Monoclonal antibodies: magic bullets with a hefty price tag. BMJ. 2012;345:e8346. doi:10.1136/bmj.e8346.
   PubMed Web of Science ®Google Scholar
• Leidner AJ, Chesson HW, Meltzer MI, et al. Guidance for Health Economics Studies Presented to the Advisory Committee on Immunization Practices (ACIP), 2019 Update [Internet]. 2019. https://www.cdc.gov/vaccines/acip/committee/downloads/Economics-Guidance-for-ACIP-2019.pdf
   Google Scholar
• Hutton DW. Economic Analysis of Nirsevimab in Pediatric Populations [Internet]. University of Michigan; 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-02/slides-02-23/RSV-Pediatric-02-Hutton-508.pdf
   Google Scholar
• Wise J. RSV: UK to examine whether to offer monoclonal antibody routinely to all babies. BMJ. 2022;379:o2725. doi:10.1136/bmj.o2725.
   PubMedGoogle Scholar
• Shetty AK, Winter MA. Immunization of children receiving immunosuppressive therapy for cancer or hematopoietic stem cell transplantation. Ochsner J. 2012;12(3):228–243.
   PubMedGoogle Scholar
• Marcotte H, Hammarström L. Chapter 71 - Passive immunization: toward magic bullets. In: Mestecky J, Strober W, Russell MW, et al. editors. Mucosal immunology. 4th edn. Boston: Academic Press; 2015. p. 1403–1434.
   Google Scholar
• Hammitt LL, Dagan R, Yuan Y, et al. Nirsevimab for prevention of RSV in healthy Late-Preterm and term infants. N Engl J Med. 2022;386(9):837–846. doi:10.1056/NEJMoa2110275.
   PubMed Web of Science ®Google Scholar
• Young B, Sadarangani S, Jiang L, et al. Duration of influenza vaccine effectiveness: a systematic review, meta-analysis, and meta-regression of Test-Negative design Case-Control studies. J Infect Dis. 2018;217(5):731–741. doi:10.1093/infdis/jix632.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. Learn more about the flu season [Internet]. Centers for Disease Control and Prevention. 2022. https://t.cdc.gov/C03
   Google Scholar
• Cohn AC, MacNeil JR, Clark TA, et al. Prevention and control of meningococcal disease: recommendations of the advisory committee on immunization practices (ACIP). MMWR Recomm Rep. 2013;62(RR-2):1–28.
   PubMed Web of Science ®Google Scholar
• Zeng Y, Luo M, Lin J, et al. Cost-effectiveness of augmenting universal hepatitis B vaccination with immunoglobulin treatment: a case study in Zhejiang province, east China. Hum Vaccin Immunother. 2020;16(4):955–964. doi:10.1080/21645515.2019.1688031.
   PubMed Web of Science ®Google Scholar